NCT00001008

Brief Summary

To determine if methadone treatment will affect the blood levels of zidovudine (AZT) in patients with AIDS or AIDS-related complex (ARC) who are receiving oral AZT and methadone therapy. In addition, the blood levels of methadone both before and during AZT treatment will be studied, and patients receiving daily oral methadone treatment will be evaluated for signs of narcotic withdrawal during treatment with AZT. The number of deaths due to AIDS in high-risk populations continues to increase. Nationwide approximately 25 percent of AIDS patients are intravenous (IV) drug abusers, and it is very likely that an increasingly larger number of AIDS patients receiving AZT therapy will have had a history of IV drug abuse. The major chemical treatment for IV drug abuse is daily methadone maintenance therapy, and IV drug abusers who are HIV positive represent a large number of patients who will undergo long-term treatment with both methadone and AZT. Therefore, the study of potential drug interactions is essential.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

March 1, 1991

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

March 14, 2011

Status Verified

August 1, 1991

First QC Date

November 2, 1999

Last Update Submit

March 11, 2011

Conditions

HIV Infections

Keywords

Substance Withdrawal SyndromeMethadoneOpioid-Related DisordersDrug EvaluationDrug InteractionsDrug Therapy, CombinationAdministration, OralAcquired Immunodeficiency SyndromeAIDS-Related ComplexZidovudine

Interventions

Methadone hydrochlorideDRUG
ZidovudineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prior Medication:
  • Allowed:
  • Oral nonabsorbable antifungal agents.
  • The study will include 18 patients with AIDS or HIV-related symptomatic illness as defined by the CDC classification group IVa and c2. Of these, 9 methadone recipients will have been maintained on methadone for at least 1 month and will have received a constant daily dose of 30-90 mg of methadone for at least 10 days.
  • Nine patients will be former intravenous drug abusers.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Temperature \> 101 degrees F.
  • Ascites.
  • Active opportunistic infection.
  • Concurrent Medication:
  • Excluded:
  • Other inducers or inhibitors of hepatic microsomal enzymes.
  • Any chronic systemic medications.
  • Patients with the following symptoms or conditions are excluded:
  • Temperature \> 101 degrees F.
  • Ascites.
  • Active opportunistic infection.
  • Prior Medication:
  • Excluded within 72 hours of study entry:
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Med Ctr / Bronx Municipal Hosp

The Bronx, New York, 10467, United States

Location

Related Publications (2)

  • Schwartz EL, Brechbuhl AB, Kahl P, Miller MH, Selwyn PA, Friedland GH. Altered pharmacokinetics of zidovudine in former IV drug-using patients receiving methadone. Int Conf AIDS. 1990 Jun 20-23;6(3):194 (abstract no SB432)

    BACKGROUND

  • Schwartz EL, Brechbuhl AB, Kahl P, Miller MA, Selwyn PA, Friedland GH. Pharmacokinetic interactions of zidovudine and methadone in intravenous drug-using patients with HIV infection. J Acquir Immune Defic Syndr (1988). 1992;5(6):619-26.

    PMID: 1588496BACKGROUND

MeSH Terms

Conditions

HIV InfectionsSubstance Withdrawal SyndromeOpioid-Related DisordersAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

MethadoneZidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSubstance-Related DisordersChemically-Induced DisordersMental DisordersNarcotic-Related DisordersSlow Virus Diseases

Intervention Hierarchy (Ancestors)

KetonesOrganic ChemicalsThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • G Friedland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Primary Completion

March 1, 1991

Last Updated

March 14, 2011

Record last verified: 1991-08

Locations

US(1)